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Safety and Efficacy Study of Vintafolide and Vintafolide Plus Paclitaxel Compared to Paclitaxel Alone in Participants With Triple Negative Breast Cancer (TNBC) (MK-8109-004)

NCT01953536 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2014-12-19

No results posted yet for this study

Summary

The purpose of this study is to assess the efficacy and safety of vintafolide alone compared to vintafolide plus paclitaxel and paclitaxel alone in participants with with 100% positive folate receptor (FR) triple negative breast cancer (TNBC).

The primary hypothesis of this study is the vintafolide alone and/or vintafolide + paclitaxel will improve progression free survival (PFS) in participants with FR (100%) TNBC compared to paclitaxel alone.

Conditions

  • Breast Neoplasms

Interventions

DRUG

Vintafolide 2.5 mg

During treatment, participants receive IV vintafolide 2.5 mg.

DRUG

Paclitaxel 80 mg/m^2

During treatment, participants receive IV paclitaxel 80 mg/m\^2.

DRUG

Etarfolatide

During screening and prior to screening CT scan, participants receive an IV injection of 0.1 mg etarfolatide radiolabeled with 20 to 25 milliCuries of technetium-99m.

DRUG

Folic acid

During screening and prior to etarfolatide injection and screening CT scan, participants receive an IV injection of 0.5 mg folic acid.

DRUG

Premedication for Paclitaxel

During treatment, participants receive dexamethasone 20 mg orally 12 to 6 hours prior to paclitaxel; OR promethazine 25 mg or 50 mg IV 30 to 60 minutes prior to paclitaxel; OR cimetidine 300 mg IV or ranitidine 50 mg IV 30 to 60 minutes prior to paclitaxel.

Sponsors & Collaborators

  • Endocyte

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-11-30
Completion
2016-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01953536 on ClinicalTrials.gov